Research Ethics and Vulnerable Group

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Research Ethics and Vulnerable Group
Prof. Dr. Wafaa E. Abdel-AalHead of Pathology
Department and Member of the RECNational
Research CenterCairo, Egypt
E Medicine Conference 29th March 2007
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Medical progress is based on research which
ultimately must rest in part on experimentation
involving human subjects. Research investigators
should be aware of the ethical, legal and
regulatory requirements.
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Scientific progress relevant to the needs of
certain populations often requires the inclusion
of vulnerable populations in clinical
research. Research with such special group
raises additional concerns because of their
vulnerability or the diminished capacity to
protect their interests.
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But who is vulnerable?!!And what is the basis of
their vulnerability?!!
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The Main Issues to be Discussed

• Definition of vulnerability
• Types of Vulnerability
• Historical background
• Safeguards to protect the rights of vulnerable
  populations
• Developing Countries and vulnerability

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Definition

• Definition vulnerable
• Susceptible to physical or emotional injury.

A condition either intrinsic or situational that
puts individuals at a greater risk of being used
in ethically inappropriate ways in research.
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CIOMS 13

• Vulnerable persons are those who are relatively
  (or absolutely) incapable of protecting their own
  interests. More formally, they may have
  insufficient power, intelligence, education,
  resources, strength, or other needed attributes
  to protect their own interests.

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Special population

• The term special population is synonymous with
  the term vulnerable subjects. Special populations
  include any subject group or community with
  qualities or characteristics that require
  specific considerations in addition to those
  required to protect the rights and welfare of a
  fully autonomous protections.

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Types of Vulnerability

• Decision making incapacity
• Cognitive vulnerability
• Situational vulnerability
• Communicative vulnerability
• Medical
• Serious health conditions
• Economic
• Undue inducements

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Types of Vulnerability

• Lack of freedom (Institutional)
• -Prisoners, military, communities in developing
  countries

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• Dependant Relationships
• -Patient and physician
• -Students, employee
• -Citizens and Government

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Who are the vulnerable groups

• Women
• Prisoners
• Children
• Mentally impaired
• Geriatric persons
• Geriatrics who have dementia? Communities in
  developing countries

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Conducting a research on children means dealing
with a vulnerable group.Pregnant women are the
most vulnerable population ..and the fetus as
well.
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Historical background

• One important theme of human experimentation that
  many subjects were from vulnerable populations
  children, mentally ill people, poor people,
  prisoners and minorities.
• Examples are

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• The Nazi experiments conducted on human beings
  stand out as clearly the worst experiments ever
  performed on human subjects. Non of the subjects
  gave informed consent, and thousands were maimed
  or killed.

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• Researchers at Vanderbilt University in late
  1940s gave pregnant women radioactive iron to
  study the effects of radiation on fetal
  development a follow-up study found that
  children from these women had a higher than
  normal cancer rate.

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• In Oregon State Prison from 1963 to 1971,
  researchers x-rayed the testicles of 67 male
  prisoners, who were mostly African Americans, to
  study the effects of radiation on sperm function.

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Safeguards to protect the rights of vulnerable
populations

• How can vulnerable subjects of research
  adequately protected against exploitation?!!
• 1- Investigators responsibility
• 2- IRB or REC responsibility
• 3- Informed consent

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• It is the investigators responsibility to
  evaluate and define clearly the expected degree
  of vulnerability , justify the involvement of
  subjects with such characteristics, and build
  into study design any additional protection that
  might be needed.

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• In addition to the safeguards for research
  subjects IRB s must ensure that there are
  additional safeguards to protect the rights and
  welfare of these subjects.
• REC should take into account
• Limit the level of risk
• Limit payment incentives

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Minimization of RiskWhat are procedures to
minimize risk?

• Substitute invasive procedures with less invasive
  ones
• Use qualified personnel
• Necessary infrastructure to handle emergencies
• Monitoring

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Safeguards to protect the rights of vulnerable
populations

• CIOMS 2002 13
• Subjects will be assured reasonable access to
  products that become available as a result of the
  research.

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Additional Protection

• Consent requirements
• Research on individuals who cannot decide
  requires surrogate consent
• children and mentally impaired

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Developing Countries and vulnerability
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• Research subjects in developing countries may be
  exploited in the international research sponsored
  by industrial countries.
• It is not fair that populations in resource-poor
  countries suffer the potential burdens of
  research without the prospect of deriving
  benefits when research demonstrates the safety
  and effectiveness of an experimental drug.

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Example of exploitation in developing countries

• Havrix Case
• Hepatitis A vaccine was tested in 1990 among
  school children's from Thailand. The study was a
  collaboration of Walter Reed Army Institute of
  research (USA) and Thailand Ministry of Public
  Health. Initially, there was a randomized ,
  double blind phase II study involving 300
  children. After demonstration of safety,

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a randomized, double- blind phase III study with
hepatitis A vaccine control involving 40,000
children was done.Prior to the phase III study,
there was no formal agreement to make Havrix
widely available in Thailand, in addition, the
company ( Smith K- line Beecham Biological) made
no commitment to provide free Havrix , no promise
about what the price would be for the private
market.
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Nevertheless, at the start of the trial, all
collaborators recognized that the largest market
for Havrix would be travelers from developed
countries.The Question is Was the Havrix
study ethical?!!
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• Despite all the protection mechanisms to
  safeguards the vulnerable populations, the gaps
  in such protection are unacceptably large.

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• Medical research should not proceed on vulnerable
  groups unless the research is specifically
  related to inherent characteristics of that group
  (and not related, for example, to the needs or
  preferences of the researchers)

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At last, Everyone of us , I think, is a
physician and /or a researcher.To be a Good
Researcher is the Golden Rule of all the story of
Ethics and Research Ethics Committees.
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Thank You